TECHFIT Digitally Integrated Surgical Reconstruction Platform (DISRP) System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the DISRP System and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including surgical guides and splints for use in maxillofacial surgery. The DISRP System is also intended as a preoperative software tool for simulating / evaluating surgical treatment options.

The DISRP system is compatible with the TECHFIT Patient- Specific Maxillofacial System and the TECHFIT Diagnostic Models and should be used in conjunction with expert clinical judgment.

Device Description

The TECHFIT DISRP SYSTEM is composed by Orthognathic Surgical Guides and the Digitally Integrated Surgical Reconstruction Platform (DISRP).

Digitally Integrated Surgical Reconstruction Platform (DISRP)
The Digitally Integrated Surgical Reconstruction Platform (DISRP) is a web-based collaboration software for digital surgery case flow management and Orthognathic surgery planning that reflects the production process and allows for the interaction of multiple users: surgeons, sales representatives, and the TECHFIT case planning staff (case planning assistant, case planners, and operations director), using multiple devices. It allows easy collaboration in the planning process. Being web-based allows immediate and convenient sharing without the installation or maintenance of the application at the user's end.

Orthognathic Surgical Guides
Orthognathic Surgical Guides are Patient-Specific single use devices that are designed to assist the surgeon in transferring the pre-surgical plan to the operation room. Surgical Guides are intended for Orthognathic surgeries in adults and have drilling holes and slots for making drillings and osteotomies, as well as they guide the correct positioning of bones and implants.

Orthognathic Surgical Guided into two types: Resin Orthognathic Surgical Guides and Machined Orthognathic Surgical Guides.

Resin Orthognathic Surgical Guides
Resin Orthognathic Surgical Guides include surgical guides and splints.

Surgical Guides consist of the Le Fort and Genioplasty surgical quides, which are composed of a body that is manufactured by TECHFIT Digital Surgery and produced by rapid prototyping with the Form 3B printer and Biomed Clear Resin from Formlabs, Somerville, United States.

In surgery Surgical Guides must be used with Metal Sleeves. There are three types of metal sleeves: slot metal sleeve, drill metal sleeve and screw metal sleeve. The slot, drill and screw metal sleeves are manually fitted by the healthcare professional during surgery into the slots, drilling holes and fixation holes of the surgical guide. The metal sleeves are produced from commercially pure titanium grade 4 through machining and are manufactured equivalent to the TECHFIT Patient-Specific Maxillofacial System (K203282) and AFFINITY Proximal Tibia System (K220199). In addition, the Metal Sleeves are single-use and patient-specific accessories.

The Splints are optional quides used in orthognathic surgery to quide to the correct teeth positioning and to validate the patient's final occlusion. The Splints are manufactured by TECHFIT Digital Surgery and produced by rapid prototyping using the Form 3B printer and Biomed Clear Resin from Formlabs, Somerville, United States.

Machined Orthognathic Surgical Guides
Machined Orthognathic Surgical Guides consist of the Le Fort and Genioplasty surgical guides that are manufactured from the same material (commercially pure titanium grade 4) and in a manufacturing process equivalent to the TECHFIT Patient-Specific Maxillofacial System (K203282) and AFFINITY Proximal Tibia System (K220199) manufactured through machining.

Machined Orthognathic Surgical Guides and Metal Sleeves are manufactured with the same material and same manufacturing process.

AI/ML Overview

The provided text describes the TECHFIT DISRP® System, including its indications for use, comparison to predicate devices, and performance data from non-clinical testing. However, it does not contain details about a study evaluating the performance of an AI/algorithm component against specific acceptance criteria related to its accuracy or diagnostic capability, nor does it mention any human-in-the-loop studies (MRMC) or standalone algorithm performance studies.

The "Performance Data" section primarily addresses:

Safety testing: Validating sterilization methods.
Performance testing: Dimensional validation (comparing physical guides to digital designs), mechanical testing (withstanding forces), and compatibility testing with other systems.
Software testing: Verification and validation of the DISRP software itself as per IEC 62304.
Biocompatibility testing: For the materials used in the surgical guides and metal sleeves.

Therefore, based solely on the provided text, I cannot fill out the requested table and details regarding acceptance criteria for an AI/algorithm and a study proving its performance in the context of diagnostic accuracy or reader improvement. The device described appears to be a software system for planning and producing physical surgical guides and splints, not an AI for image interpretation or diagnosis.

If the "DISRP System" inherently contains an AI component for, say, auto-segmentation or surgical plan optimization that would require diagnostic-like performance evaluation, that information is not present in the provided excerpt.

Assuming the request refers to the acceptance criteria for the overall system's performance as described, rather than an AI's diagnostic accuracy:

Here's how I can address the request based on the available information, while highlighting what's not present:

Response based on the provided document:

The provided document describes the TECHFIT DISRP® System, which is a software system and image segmentation system used for surgical planning and the production of physical surgical guides and splints. It is not an AI diagnostic device in the traditional sense that generates clinical interpretations or provides diagnostic classifications. Therefore, the acceptance criteria and study details commonly associated with AI performance validation (like sensitivity, specificity, MRMC studies, ground truth establishment for diagnostic tasks) are not applicable to the data presented in this FDA 510(k) summary.

The performance data presented focuses on the physical and software validation of the device, ensuring it meets its intended use of accurately transferring imaging information to produce dimensionally correct and mechanically sound surgical guides and splints, and that the software functions as intended.

Here's a breakdown based on the provided text, addressing the points where information is available or noting its absence:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (for the system's function/physical output)	Reported Device Performance (from "Performance Data")
Dimensional Validation: Orthognathic surgical guides maintain proportions and dimensions of original digital design after manufacturing and sterilization.	Conclusion: "DISRP and Orthognathic surgical guides maintain the proportions and dimensions of the original digital design after manufacturing and sterilization." (Test Method: "Scanning of orthognathic surgical guides and then comparing them versus the original files, before and after sterilization.")
Mechanical Testing: Orthognathic surgical guides can withstand maximum bite force, drilling force, and general surgical handling force.	Conclusion: "Orthognathic Surgical Guides withstand bit force and the force applied by the surgeon during handling." (Test Method: "Bending and compressive strength, after sterilization. Evaluating if the orthognathic surgical guides can withstand the maximum bite force, force required for drilling and handle force required for a general surgery.")
Software Validation: Software meets IEC 62304 standards for verification and validation.	Conclusion: "DISRP software was verified and validated as per IEC 62304." (Test Method: "Software verification and validation activities")
Sterilization Efficacy: Achieves a Sterility Assurance Level (SAL) of 10^-6 for steam sterilization.	Conclusion: "The results of the steam sterilization validation show that TECHFIT Orthognathic Surgical Guides sterilized to a SAL of 10^-6 using the recommended steam sterilization instructions." (Test Method: AAMI/ISO 17665-1:2006/(R)2013 and ANSI/AAMI/ISO 14937:2009/(R)2013)
Biocompatibility (Resin Guides): No cytotoxic, sensitizing, irritant, acute systemic toxicity, pyrogenic, or genotoxic properties. Non-toxic chemical characterization.	Conclusion: All biocompatibility tests (Cytotoxicity, Sensitization, Irritation, Acute systemic toxicity, Pyrogenicity, Chemical Characterization) were concluded with "No..." or "Non-toxic" findings in compliance with respective ISO standards (ISO 10993-5, 10993-10, 10993-11, 10993-18, 10993-17).
Biocompatibility (Machined Guides/Sleeves): No cytotoxic, sensitizing, irritant, acute systemic toxicity, pyrogenic, or genotoxic properties. Non-toxic chemical characterization.	Conclusion: All biocompatibility tests (Cytotoxicity, Sensitization, Irritation, Acute systemic toxicity, Pyrogenicity, Genotoxicity, Chemical Characterization) were concluded with "No..." or "Non-toxic" findings in compliance with respective ISO standards (ISO 10993-5, 10993-10, 10993-11, 10993-3, 10993-18, 10993-17).
Compatibility: Compatible with the Maxillofacial System and Metal Sleeves.	Conclusion: "Orthognathic Surgical Guides are compatible with the Maxillofacial System and Metal Sleeves." (Test Method: "Verifying compatibility between the Maxillofacial System and orthognathic surgical guides")

Details Regarding Studies (as pertains to this type of device):

Sample sizes used for the test set and the data provenance:
- The document mentions "Scanning of orthognathic surgical guides" and "Bending and compressive strength" tests but does not specify the sample size (number of guides or tests performed) for these non-clinical performance validations.
- The data provenance is not explicitly stated in terms of country of origin for test materials or whether tests were retrospective or prospective, beyond general statements about testing performed for FDA submission. These are typical engineering validation tests, not clinical trials.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for this type of device validation. The "ground truth" here is based on engineering specifications, material properties, and adherence to digital designs, not expert clinical interpretation of images.
Adjudication method for the test set:
- Not applicable. This is not a human-reader study requiring adjudication for diagnostic accuracy.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. An MRMC study was not described. This device is for surgical planning and guide production, not for AI-assisted diagnostic interpretation by human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "Software testing" indicates that the "DISRP software was verified and validated as per IEC 62304," which is a standard for medical device software lifecycle processes. This constitutes a standalone validation of the software's functionality and safety, but not a performance evaluation in terms of diagnostic accuracy or interpretation, as it is not a diagnostic AI.
The type of ground truth used:
- The ground truth for the dimensional validation is the original digital design files of the surgical guides.
- For mechanical testing, the ground truth is engineering specifications for load-bearing capacity (e.g., maximum bite force, drilling force).
- For software validation, the ground truth is the specified software requirements and the IEC 62304 standard.
- For biocompatibility, the ground truth is the ISO 10993 series of standards for biological evaluation of medical devices.
The sample size for the training set:
- Not applicable. This document does not describe a machine learning algorithm that requires a training set. The "DISRP System" is described as a "software system and image segmentation system for the transfer of imaging information," implying rule-based or conventional image processing for segmentation rather than a data-driven AI model that learns from large training datasets.
How the ground truth for the training set was established:
- Not applicable as no training set for an AI model is described.

Summary

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June 23, 2023

TECHFIT Digital Surgery Angela María Lema-Pérez Regulatory Affairs Specialist 1511 Aviation Center Pkwy Suite 220H Daytona Beach, Florida 32114

Re: K230276

Trade/Device Name: TECHFIT DISRP® System Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: DZJ, LLZ Dated: May 30, 2023 Received: May 30, 2023

Dear Angela María Lema-Pérez:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Bobak Shirmohammadi -S

For Michael E. Adjodha, M.ChE., CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230276

Device Name TECHFIT DISRP® SYSTEM

Indications for Use (Describe)

The DISRP system is compatible with the TECHFIT Patient- Specific Maxillofacial System and the TECHFIT Diagnostic Models and should be used in conjunction with expert clinical judgment.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo features a blue sphere with a gray teardrop shape overlapping it on the left side. To the right of the sphere, the word "TECHFIT" is written in gray, block letters. Below "TECHFIT", the words "Digital Surgery" are written in a smaller, gray font.

K230276 - 510(k) summary 1

The 510(k) summary is provided on the following page per 21 CFR 807.92(c).

510(k) summary

The following section is included as required by the Safe Medical Devices Act (SMDA) of 1990 and 21CFR 807.92

1.1 Submitter information

Table 1. Submitter information

Company name	TECHFIT Digital Surgery
Establishment registration number	3004187715
Street Address	1511 Aviation Center PkwySuite 220H
City	Daytona Beach
Zip code	FL 32114
Country	United States
Phone number	+57 604 322-33-75 Ext. 165
Fax number	+57 604 3383013
Principal contact person	Angela María Lema-Pérez
Contact title	Regulatory Affairs Specialist
Contact e-mail address	angela.lema@techftids.com
Additional contact person	Susana Muñoz-Cuartas
Contact title	Regulatory Affairs Specialist
Contact e-mail address	susana.munoz@techfitds.com

1.2 Date Prepared

June 22, 2023.

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1.3 Submission information

Table 2. Submission information
Trade name	TECHFIT DISRP® SYSTEM
Common or Usual name	DISRP
Classification name	21 CFR 872.4120
Product code (classification regulation)	DZJ, LLZ
Classification Panel	Dental
Device class	Class II

1.4 Predicate device

The primary devices to which substantial equivalence is claimed to:

Table 3. Primary predicate device
Primary predicate: KLS Martin Individual Patient Solutions (IPS) Planning system
Trade or proprietary or model name	KLS Martin Individual Patient Solutions (IPS) Planning System
510(k) number	K182789
Decision date	2019/03/11
Product code	DZJ, LLZ
Manufacturer	KLS-Martin L.P.

Table 3. Primary predicate device

1.5 Reference devices

The general information of the reference devices is the following:

			Table 4. Reference Device 1
--	--	--	-----------------------------	--	--

Secondary predicate: IPS CaseDesigner 2.0
Trade or proprietary or model name	IPS CaseDesigner 2.0
510(k) number	K200810
Decision date	2020/10/08
Product code	LLZ
Manufacturer	Nobel Biocare AB

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Table 5. Reference Device 2

Reference device 1: TECHFIT Patient-Specific Maxillofacial System
Trade or proprietary or model name	TECHFIT Patient-Specific Maxillofacial System
510(k) number	K203282
Decision date	2021/05/19
Product code	JEY
Manufacturer	TECHFIT Digital Surgery INC.

Table 6. Reference Device 3

Reference device 2: AFFINITY Proximal Tibia System
Trade or proprietary or model name	AFFINITY Proximal Tibia System
510(k) number	K220199
Decision date	2022/03/21
Product code	HRS, HWC
Manufacturer	Industrias Medicas Sampedro S.A.S

1.6 Device Information

Table 7 presents the device information of the subject device and predicate devices.

	Subject device:TECHFITSYSTEMDISRP®	Primary predicate device:KLS Martin IndividualPatient Solutions (IPS)Planning System(K182789)
Product code	DZJ, LLZ	DZJ, LLZ
Classification	21 CFR 872.4120, Class II21 CFR 892.2050, Class II	21 CFR 872.4120,Class II21 CFR 892.2050,Class II
Intended Use	TECHFIT Digitally IntegratedSurgical ReconstructionPlatform (DISRP) System isintended for use as a softwaresystem and imagesegmentation system for thetransfer of imaginginformation from a medical	The KLS MartinIndividual PatientSolutions (IPS)Planning System isintended for use as asoftware system andimage segmentation

Table 7. Device information

510(k) Premarket Notification

TECHFIT DIGITAL SURGERY

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Image /page/6/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo features a blue and gray sphere on the left, followed by the word "TECHFIT" in gray, sans-serif font. Below "TECHFIT" is the phrase "Digital Surgery" in a smaller, gray, sans-serif font. The logo is clean and modern, and the colors are professional and calming.

1.6.1 Device Description

The TECHFIT DISRP SYSTEM is composed by Orthognathic Surgical Guides and the Digitally Integrated Surgical Reconstruction Platform (DISRP).

Digitally Integrated Surgical Reconstruction Platform (DISRP)

The Digitally Integrated Surgical Reconstruction Platform (DISRP) is a web-based collaboration software for digital surgery case flow management and Orthognathic surgery planning that reflects the production process and allows for the interaction of multiple users: surgeons, sales representatives, and the TECHFIT case planning staff (case planning assistant, case planners, and operations director), using multiple devices. It allows easy collaboration in the planning process. Being web-based allows immediate and convenient sharing without the installation or maintenance of the application at the user's end.

Orthognathic Surgical Guides

510(k) Premarket Notification	TECHFIT DIGITAL SURGERY
-------------------------------	-------------------------

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Image /page/7/Picture/1 description: The image shows the logo for Techfit Digital Surgery. The logo consists of a blue sphere with a smaller, gray sphere partially overlapping it on the left side. To the right of the spheres, the word "TECHFIT" is written in gray capital letters, with the words "Digital Surgery" written in a smaller font size below it.

Orthognathic Surgical Guides are Patient-Specific single use devices that are designed to assist the surgeon in transferring the pre-surgical plan to the operation room. Surgical Guides are intended for Orthognathic surgeries in adults and have drilling holes and slots for making drillings and osteotomies, as well as they guide the correct positioning of bones and implants.

Orthognathic Surgical Guided into two types: Resin Orthognathic Surgical Guides and Machined Orthognathic Surgical Guides.

Resin Orthognathic Surgical Guides ●
Resin Orthognathic Surgical Guides include surgical guides and splints.

Machined Orthognathic Surgical Guides .
Machined Orthognathic Surgical Guides consist of the Le Fort and Genioplasty surgical guides that are manufactured from the same material (commercially pure titanium grade 4) and in a manufacturing process equivalent to the TECHFIT Patient-Specific Maxillofacial System (K203282) and AFFINITY Proximal Tibia System (K220199) manufactured through machining.

Machined Orthognathic Surgical Guides and Metal Sleeves are manufactured with the same material and same manufacturing process.

1.6.2 Indications for use

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surgical guides and splints for use in maxillofacial surgery. The DISRP System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.

The DISRP system is compatible with the TECHFIT Patient- Specific Maxillofacial System and the TECHFIT Diagnostic Models and should be used in conjunction with expert clinical judgment.

2 Comparison to Predicate Devices

Both subject device and primary predicate have the same indications for use: orthognathic surgery, including Le Fort and Genioplasty Surgical Guides and splints, reconstructive surgery, and trauma of the midface and maxillofacial skeleton. A device comparison table is more detailed in section 12 and Table 8.

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Table 8. Comparison to predicate device - an overview.

Criteria	Subject device	Primary predicate	Reference device 1	Reference device 2	Reference device3
510K number	TECHFIT DISRP®SYSTEM	KLS Martin IndividualPatient Solutions (IPS)Planning System	IPS CaseDesigner2.0	TECHFIT Patient-SpecificMaxillofacialsystem	AFFINITYProximal TibiaSystem
510K number	K230276	K182789	K200810	K203282	K220199
Indications forUse	TECHFIT DigitallyIntegrated SurgicalReconstruction Platform(DISRP) System isintended for use as asoftware system andimage segmentationsystem for the transfer ofimaging information froma medical scanner suchas a CT based system.The input data file isprocessed by the DISRPSystem and the result isan output data file thatmay then be provided asdigital models or used asinput to a rapidprototyping portion of thesystem that producesphysical outputs includingsurgical guides and splintsfor use in maxillofacialsurgery. The DISRPSystem is also intendedas a pre-operativesoftware tool forsimulating / evaluatingsurgical treatment options.	The KLS MartinIndividual PatientSolutions (IPS) PlanningSystem is intended foruse as a software systemand image segmentationsystem for the transfer ofimaging information froma medical scanner suchas a CT based system.The input data file isprocessed by the IPSPlanning System, and theresult is an output datafile that may then beprovided as digitalmodels or used as inputto a rapid prototypingportion of the system thatproduces physicaloutputs includinganatomical models,guides, splints, and casereports for use inmaxillofacial surgery. TheIPS Planning System isalso intended as a pre-operative software tool	IPS CaseDesigner isindicated for use as asoftware and imagesegmentation systemfor the transfer ofimaging informationfrom a scanner suchas a CT scanner. It isalso indicated tosupport the diagnosticand treatmentplanning process ofcraniomaxillofacialprocedures. IPSCaseDesignerfacilitates the serviceoffering ofindividualized surgicalaids.	TECHFIT Patient-Specific MaxillofacialSystem is intendedfor use in thestabilization, fixation,and reconstruction ofthemaxillofacial/midfaceand mandibularskeletal regions.	AFFINITY ProximalTibia System isintended to treatfractures,nonunions,malunions of theproximal tibiaincluding simple,comminuted,lateral wedgedepression, medialwedge, bicondylarcombination oflateral wedge anddepression,periprosthetic, andfractures withassociated shaftfractures.-Simplemetaphysealfractures(Classification AO41-A2)-Multifragmentarymetaphysealfractures(Classification AO

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Image /page/11/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo consists of a blue sphere with a white teardrop shape overlapping it on the left side. To the right of the sphere is the word "TECHFIT" in a simple, sans-serif font, and below that is the phrase "Digital Surgery" in a smaller font.

The DISRP system iscompatible with theTECHFIT Patient- SpecificMaxillofacial System andthe TECHFIT DiagnosticModels and should beused in conjunction withexpert clinical judgment	surgical treatmentoptions.			-Simple bicondylarfractures(ClassificationAO41-C1, 41-C2)-Multifragmentarybicondylarfractures(Classification AO41-C3)-Simple jointsimplemetaphysealfractures(Classification AO41-C1)-Diaphisaryfractures(Classification AO42A and 42B)
Clinical Use	Orthognathic treatment	Maxillofacial andorthognathic treatment	Cranio-maxillofacialand orthognathictreatment	Maxillofacial/Midface & Mandible	OrthopedicProximal tibialcondyles
Product Code	DZJ, LLZ	DZJ, LLZ	LLZ	JEY	HRS, HWC

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Classification	21 CFR 872.4120, Class II21 CFR 892.2050, Class II	21 CFR 872.4120, Class II21 CFR 892.2050, Class II	21 CFR 892.2050,Class II	21 CFR 872.4760,Class II	21 CFR 888.3030,Class II
TargetPopulation	Adults	Pediatric & Adults	Adults	Adults	Adults
Image Import	DICOM data format fromCT/CBCT scanner3D models and surfacescan data in generic openfile format (STL)	DICOM data format fromCT scanner 3D modelsand surface scan data ingeneric open file format(STL).	DICOM data formatfrom CT/CBCTscanner3D models andsurface scan data ingeneric open fileformat (STL)	DICOM data formatfrom CT/CBCTscanner3D models andsurface scan data ingeneric open fileformat (STL)	No
Softwareoutput	Encrypted STL file withdesign of the final patientspecific device such assurgical guides, splintsand case reports	N.A.	Encrypted STL filewith design of the finalsplint for centralizedmanufacturing at KLSMartin	N.A	N.A
	3D Visualization	2D and 3D Visualization	2D and 3DVisualization	N.A	N.A
	Distance and anglemeasurements	Distance and anglemeasurements	Distance and anglemeasurements	N.A	N.A
Softwarefunctions	Bone fragments can bemoved in the 3D space(translations androtations) in order to planthe ideal post-operativeposition of each fragment.Supported osteotomies:Le Fort I, Chin, Splint	Bone fragments can bemoved in the 3D space(translations androtations) in order to planthe ideal post-operativeposition of eachfragment.Supported osteotomies:Le Fort I, Sagittal, Splint,Ramus, Chin	Bone fragments canbe moved in the 3Dspace (translationsand rotations) in orderto plan the ideal post-operative position ofeach fragment.Supportedosteotomies:Le Fort I, Sagittal,Splint, Ramus, Chin,Segmental (Split, Y-cut, H-cut)	N.A	N.A
	3D Surgical Modelcreation from CBCT/CTscan data and STL file	3D Surgical Modelcreation fromCT scan data	3D Surgical Modelcreation fromCBCT/CT scan dataand STL file	N.A	N.A
Softwarefunctions	3D photo mapping	Soft tissue simulation	Soft tissue simulation,3D photo mapping	N.A	N.A

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Image /page/13/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo features a blue sphere with a gray teardrop shape overlapping it on the left side. To the right of the sphere are the words "TECHFIT" in a simple, sans-serif font, with the words "Digital Surgery" in a smaller font below.

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Image /page/14/Picture/0 description: The image contains the logo for Techfit Digital Surgery. The logo consists of a blue sphere with a gray teardrop shape overlapping it on the left side. To the right of the sphere and teardrop is the word "TECHFIT" in gray, block letters, with the words "Digital Surgery" in a smaller font below it.

Based on the createdorthognathic plan the usercan export surgical guidesand splints order files.These files can be used tocalculate and produceorthognathic surgicalguides and splints in theproduction backend	Based on the createdorthognathic plan theuser can export surgicalsplint order files. Thesefiles can be used tocalculate and produceorthognathic splints in theproduction backend	Based on the createdorthognathic plan theuser can exportsurgical splint orderfiles. These files canbe used to calculateand produceorthognathic splints inthe productionbackend	N.A	N.A
DISRP: the user cancreate a list of requiredosteosynthesis platesbased on a createdsurgical plan.	N.A.	Osteosynthesis Plates& IPS Gate: the usercan create a list ofrequiredosteosynthesis platesbased on a createdsurgical plan.	N.A	N.A

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Image /page/15/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo features a blue sphere with a gray teardrop shape overlapping it on the left side. To the right of the sphere, the word "TECHFIT" is written in gray, uppercase letters. Below "TECHFIT", the words "Digital Surgery" are written in a smaller, gray font.

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Image /page/16/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo consists of a blue sphere with a gray teardrop shape partially overlapping it on the left side. To the right of the sphere are the words "TECHFIT" in a simple, sans-serif font, with the words "Digital Surgery" in a smaller font below.

	- New algorithm forocclusion alignment- New algorithm for virtualocclusion	N.A.	New algorithmfor occlusionalignment - Newalgorithm forvirtualocclusion	N.A	N.A
Operatingsystemrequirements	Operating system:Windows 64-bit (Windows7 and/or later)Mac OS (Yosemite orlater)	Windows 64-bit(Windows 7, 8,10)Mac OS X (Yosemite, ElCapitan)	Windows 64-bit(Windows 7, 10)Mac OS Catalina,Mojave, High Sierra	N.A	N.A
Material	Resin OrthognathicSurgical guides: BiomedClear Resin.Machined OrthognathicSurgical Guides: CPTitanium.Metal sleeves: CPTitanium.	Anatomical Models:Epoxy/Resin, AcrylicCutting/Marking Guides:Polyamide, Titanium Alloy(Ti-6Al-4V), CP TitaniumSplints: methacrylate	Not available	CP Titanium	CP Titanium

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Image /page/17/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo features a blue sphere with a gray crescent shape partially overlapping it on the left side. To the right of the sphere and crescent is the word "TECHFIT" in a simple, sans-serif font, with the words "Digital Surgery" in a smaller font below it.

ManufacturingMethod	Resin: 3D printing -Stereolithography (SLA).CP Titanium: Traditional(Subtractive)	Epoxy/Resin, Acrylic:Stereolithography (SLA)CP Titanium: Traditional(Subtractive)Ti-6Al-4V: 3D (Additive;Selective Laser Melting)Polyamide: 3D (Additive;Selective Laser Sintering)	Not available	Traditional(Subtractive)	Traditional(Subtractive)
Sterilization	Non-sterile (Steam)	Non-sterile (Steam)	Not available	Non-sterile (Steam)	Non-sterile(Steam)
Manufacturer	TECHFIT Digital Surgery	KLS Martin	Nobel Biocare	TECHFIT DigitalSurgery	Industrias MédicasSampedro
Patient-specificconfiguration?	Yes. Devices aremanufactured patient-specific, based on a CTscan of the patient	Yes. Devices aremanufactured patient-specific, based on a CTscan of the patient	Yes	Yes. Devices aremanufacturedpatient-specific,based on a CT scanof the patient	No. The plates arestandardmanufacturedplates

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Image /page/18/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo consists of a blue sphere with a gray teardrop shape overlapping it on the left side. To the right of the sphere is the word "TECHFIT" in gray, all-caps lettering. Below "TECHFIT" are the words "Digital Surgery" in a smaller, gray font.

3 Performance data

The following non-clinical testing was conducted as a basis for the determination of substantial equivalence:

Name	Test method	Conclusion
Safety testing
Validating sterilizationmethods	AAMI/ISO 17665-1:2006/(R)2013Sterilization of health care products- Moist heat - Part 1 Requirementsfor the development, validation androutine control of a sterilizationprocess for medical devices.ANSI/AAMI/ISO14937:2009/(R)2013 Sterilization ofHealthcare Products -GeneralRequirements for Characterizationof a Sterilizing Agent and theDevelopment, Validation andRoutine Control of a SterilizationProcess for Medical Devices.	The results of the steamsterilization validationshow that TECHFITOrthognathic SurgicalGuides sterilized to aSAL of 10-6 using therecommended steamsterilization instructions
Performance testing
Dimensional validation	Scanning of orthognathic surgicalguides and then comparing themversus the original files, before andafter sterilization.	DISRP andOrthognathic surgicalguides maintain theproportions anddimensions of theoriginal digital designafter manufacturing andsterilization.
Mechanical testing	Bending and compressive strength,after sterilization. Evaluating if theorthognathic surgical guides canwithstand the maximum bite force,force required for drilling and handleforce required for a general surgery.	Orthognathic SurgicalGuides withstand bitforce and the forceapplied by the surgeonduring handling.
Compatibility testing	Verifying compatibility between theMaxillofacial System andorthognathic surgical guides	Orthognathic SurgicalGuides are compatiblewith the MaxillofacialSystem and MetalSleeves.
Software testing	Software verification and validationactivities	DISRP software wasverified and validated asper IEC 62304

Table 9. Performance data

TECHFIT DIGITAL SURGERY

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Image /page/19/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo features a blue sphere with a gray semi-circle overlapping it on the left side. To the right of the sphere, the word "TECHFIT" is written in gray, all-caps letters. Below "TECHFIT", the words "Digital Surgery" are written in a smaller, gray font.

Biocompatibility testing .
Resin Orthognathic Surgical Guides are manufactured with Biomed Clear (Formlabs). The following are the tests summarizes the biocompatibility testing:

	Table 10. Overview of Biomed Clear biocompatibility testing
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Test / Assessment Description	Test Report Conclusion
Cytotoxicity:ISO 10993-5	No cytotoxic effect properties incompliance with requirements ofthe ISO 10993-5 guidelines
Sensitization:ISO 10993-10	No sensitizing properties incompliance with requirements ofthe ISO 10993-10 guidelines
Irritation:ISO 10993-10	No irritant properties in compliancewith requirements of the ISO10993-10 guidelines
Acute systemic toxicity:ISO 10993-11 and USP <88>	No evidence of systemic toxicitytest passed and is considerednegative based on standards set byISO 10993-11
Pyrogenicity:ISO 10993-11	No pyrogenic properties incompliance with requirements ofthe ISO 10993-11
Chemical Characterization and riskassessment:ISO 10993-18 and ISO 10993-17	Non-toxic chemical characterizationas per ISO 10993-18 and ISO10993-17 standards

An overview of TECHFIT's biocompatibility testing is shown below:

Table 11. Overview of TECHFIT biocompatibility testing for Resin Orthognathic Surgical Guides

Test / Description	Assessment	Test Report Conclusion
Cytotoxicity:ISO 10993-5		No cytotoxic effect properties in compliance with requirements of the ISO 10993-5 guidelines
Sensitization:ISO 10993-10		No sensitizing properties in compliance with requirements of the ISO 10993-10 guidelines
Irritation:ISO 10993-23		No irritant properties in compliance with requirements of the ISO 10993-10 guidelines

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Image /page/20/Picture/0 description: The image shows the Techfit Digital Surgery logo. The logo features a blue sphere with a gray teardrop shape overlapping it on the left side. To the right of the sphere, the word "TECHFIT" is written in gray, with the words "Digital Surgery" written in a smaller font size below it.

Machined Orthognathic Surgical Guides and Metal Sleeves are manufactured with commercially pure Titanium grade 4. The following are the tests summarizes the biocompatibility testing:

Table 12. Overview of TECHFIT biocompatibility testing for Machined Orthognathic Surgical Guides and Metal Sleeves.

Test / Assessment Description	Test Report Conclusion
Cytotoxicity:ISO 10993-5	No cytotoxic effect properties incompliance with requirements ofthe ISO 10993-5 guidelines
Sensitization:ISO 10993-10	No sensitizing properties incompliance with requirements ofthe ISO 10993-10 guidelines
Irritation:ISO 10993-10	No irritant properties in compliancewith requirements of the ISO10993-10 guidelines
Acute systemic toxicity:ISO 10993-11	No evidence of systemic toxicitytest passed and is considerednegative based on standards set byISO 10993-11
Pyrogenicity:ISO 10993-11	No pyrogenic properties incompliance with requirements ofthe ISO 10993-11
Genotoxicity:ISO 10993-3	No genotoxicity properties incompliance with requirements ofthe ISO 10993-3
Chemical Characterization and riskassessment:ISO 10993-18 and ISO 10993-17	Non-toxic chemical characterizationas per ISO 10993-18 and ISO10993-17 standards

4 Conclusion

Non-clinical tests demonstrate that the DISRP System is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 872.4120 Bone cutting instrument and accessories.

(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.